Skip to main content

Table 1 Baseline demographics and characteristics of patients from the double-blind, placebo-controlled and cumulative periods

From: Risk of opportunistic infections in patients with rheumatoid arthritis initiating abatacept: cumulative clinical trial data

 

Double-blind, placebo*-controlled period

Cumulative period

 

Abatacept (N = 2653)

Placebo (N = 1485)

Abatacept (N = 7044)

Patient demographics

 Age, years

51.7 (12.4)

51.4 (12.3)

51.5 (12.6)

 Weight, kg

73.5 (18.8)

n = 2650

73.8 (18.6)

n = 1484

74.4 (19.0)

n = 7036

 Female, n (%)

2099 (79.1)

1184 (79.7)

5675 (80.6)

 White, n (%)

2283 (86.1)

1285 (86.5)

5940 (84.3)

 Durations of exposure, months

10.8 (3.3)

10.3 (3.5)

36.9 (26.2)

Disease characteristics

 Disease duration, years

8.1 (8.5)

n = 2577

7.5 (8.5)

n = 1439

8.1 (8.6)

n= 6933

 hsCRP, mg/L

26.3 (29.8)

n = 2567

27.2 (33.5)

n = 1435

24.8 (29.8)

n = 6936

 Tender joint count (28)

29.8 (13.9)

n = 1618

29.9 (13.8)

n = 960

28.9 (14.2)

n = 4545

 Swollen joint count (28)

20.9 (10.2)

n = 1618

20.9 (9.8)

n = 960

19.8 (9.9)

n = 4545

 HAQ-DI

1.5 (0.7)

n = 2559

1.6 (0.7)

n = 1427

1.6 (0.7)

n = 6895

 Patient pain (0–100 VAS)

63.4 (21.0)

n = 2212

63.4 (21.1)

n = 1173

64.3 (21.1)

n = 5514

Concomitant medications

 NSAIDs, n (%)

2238 (84.4)

1269 (85.5)

5668 (80.5)

 Oral glucocorticoids, n (%)

1499 (56.5)

823 (55.4)

4285 (60.8)

  Oral dose, mg

7.5 (8.1)

9.1 (9.1)

12.3 (162.5)

 MTX, n (%)

1809 (68.2)

948 (63.8)

5184 (73.6)

 Anti-TNF, n (%)

169 (6.4)

82 (5.5)

262 (3.7)

  1. All values are mean (SD) unless otherwise stated
  2. HAQ-DI health assessment questionnaire-disability index, hsCRP high-sensitivity C-reactive protein, MTX methotrexate, NA not available, NSAID non-steroidal anti-inflammatory drug, TNF tumor necrosis factor, VAS visual analog scale
  3. *Excluding adalimumab arm in the AMPLE trial and infliximab arm in the ATTEST trial; background therapy, including methotrexate and corticosteroids, was permitted in the placebo arms
  4. VAS: 0 = no pain and 100 = worst possible pain
  5. Up to the last dose of study medication